SUPPLY CHAIN ARTICLES

  • ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!)

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

  • A "Hot Take" on Personalized mRNA Medicines

    mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.

  • From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy

    In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact. 

  • mRNA Vaccines: Key Considerations For Development & Manufacturing

    As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more. 

  • 4 Risk Mitigation Strategies For mRNA Production

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

  • The RNA Therapeutics Supply Chain: A Platform of Relationships

    Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.

SUPPLY CHAIN VIDEOS

In this Advancing RNA Live clip, CMC consultant Sujit Jain unpacks the levels of maturity he’s observed in process and analytical development, as well as supply chain. While vaccines and liver-targeting therapeutics boast what we can call a reproducible platform today, targeted LNP therapies introduce a handful of scale-up sensitivities and characterization hurdles.

The mRNA supply chain is undergoing massive growth in three particular areas. Here, speakers Khaled Yamout & Francoise Ribes walk us through the materials that have undergone the most scientific growth over the past few years and the impacts they’re noting these advancements having on the development of our mRNA drug substances and mRNA-LNP drug products. 

Three experts in cold chain management walk through the advantages of end-to-end platforms for bulk drug substance management.

In this opening Advancing RNA Live clip, panelists Max De Long, April Sena, and Venkat Krishnamurthy share the biggest scientific and manufacturing breakthrough made in the world of gRNA production over the past year. 

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS